Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure; Growth Hormone Deficiency
• Intervention / Treatment: Drug: Somatotropin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Department of Internal Medicine, Cardiovascular and Immunological Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
• Age range 18-80 years
• Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
• Left Ventricular ejection fraction 40% or less
• Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
• Written Informed consent

Exclusion Criteria:

• Acute proliferative or severe non-proliferative diabetic retinopathy
• Active malignancy
• Evidence of progression or recurrence of an underlying intracranial tumor
• Unstable Angina or recent myocardial infarction
• Serum Creatinine levels > 2.5 mg/dl
• Severe liver disease (Child-Pugh B-C)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GH replacement; Patients will receive 48 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,012 mg/kg every second day, added to their background optimized CHF therapy	Drug: Somatotropin; Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
No Intervention: Control CHF patients under optimized CHF therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Oxygen Consumption	after 48 months
Side effects	Any side effects recorded after 6,24 and 48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Left Ventricular Ejection Fraction	after 48 months
Left Ventricular End-Systolic Volume	after 48 months
Left Ventricular End-Diastolic Volume	after 48 months
Quality of Life	after 48 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Long-Term GH in CHF